The Importance of Erring on The Side of Caution When Interpreting Borderline Squamous or Inadequate Smear Tests

The Importance of Erring on The Side of Caution When Interpreting Borderline Squamous or Inadequate Smear Tests

A Case Example

In this case, the patient attended a routine smear test at their GP Surgery. The sample was examined at the local hospital and was reported as normal.

Two years later the patient collapsed and was taken to A&E. Following investigation, the patient was found to have Cervical Cancer and sadly lost their life some months later. On closer inspection of the original smear test which had been reported as normal, a few abnormal cells can be seen indicating, at the very least, that the test should have been repeated or a referral made for a colposcopy (a minor procedure to look in closer detail at the cervix surface).

There were so few cells on the slide of the sample that it was not possible to conclude that it was a normal specimen. It should have been reported as an inadequate test result and a second test performed.

An Increased Litigation Risk for Healthcare Providers.

TMLEP would like to highlight the litigation risk posed and the potential for claims in respect of cases of smear tests. TMLEP have provided recommendations to enhance patient safety and reduce litigation risk.

  • It is recommended that if a smear test slide has overall low cellularity, (i.e. too few cells) then the outcome should be recorded as an inadequate report. An inadequate test result means that the test must be repeated within 3 months. A negative report should only be reported if the cytologist is confident that the sample contains a sufficient amount of cells to make that judgement.

  • It is recommended smear tests which show borderline changes should prompt a repeat sample in 6 months or further investigation and referral for colposcopy or prompt an inadequate report which would require the test to be repeated.

To Summarise

In this case, the fact that the sample contained so few cells should have prompted the cytologist to report it as inadequate and therefore inconclusive rather than negative. The abnormal cells at the time of the original smear test indicated CIN (Cervical Intraepithelial Neoplasia) and so were confined to the epithelium of the cervix. By the time of the investigation two years later, they were diagnosed at Stage IV and had spread and ultimately proved terminal. The few cells that indicated even the slightest possibility of borderline squamous changes should have prompted a repeat sample in 6 months or referral for colposcopy.

References

  • https://www.nhs.uk/conditions/cervical-screening/
  • https://healthtalk.org/cervical-screening/normal-and-inadequate-test-results
  • Co-written by The TMLEP Clinical Risk and Patient Safety Publishing Group, Alice Price, TMLEP Marketing and Communications Executive and Mr Mark Howard, Consultant Biomedical Scientist in Cervical Cyt. (2020). The Importance of Erring on The Side of Caution When Interpreting Borderline Squamous or Inadequate Smear Tests. TMLEP Clinical Risk Case Studies. 4 (7), 1.

Important Note

This article is intended to raise awareness to clinical risk issues in an effort to reduce incidence recurrence and improve patient safety. This is not intended to be relied upon as advice. Facts have been altered to ensure this case is non-identifiable, albeit clinical learning points remain applicable. To request an independent clinical review, please contact admin@tmlep.com or call +44 (0) 203 355 9796.